BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

    MDR report key: 1083512 · Received July 29, 2008

    Report

    Report Number
    2953200-2008-00611
    Event Type
    Death
    Date Received
    July 29, 2008
    Date of Event
    June 29, 2008
    Report Date
    June 30, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SECONDARY INTERVENTION. EVALUATION CODES: RESULTS: SUBACUTE THROMBOSIS, MI, DEATH.

    Description of Event or Problem · 1

    FOUR ENDEAVOR MX2 DRUG-ELUTING CORONARY STENTS WERE SUCCESSFULLY IMPLANTED INTO A PATIENT FOR TREATMENT OF A PROXIMAL AND MID RCA; AND A PROXIMAL AND MID CIRCUMFLEX ARTERY. THE VESSEL MORPHOLOGY WAS NOT REPORTED. IT IS UNKNOWN IF THE LESION WAS PRE-DILATED. (MFR REPORT# 2953200-2008-00611-00614) IT WAS REPORTED FIVE DAYS POST STENT IMPLANT THAT THE PATIENT PRESENTED EMERGENTLY TO THE ER WITH SUB ACUTE STENT THROMBOSIS. THE PATIENT WAS REPORTED TO HAVE POBA; THEN WAS TRANSFERRED TO THE ICU. IT WAS REPORTED THAT THE PATIENT EXPIRED THE FOLLOWING DAY. THE PHYSICIAN SUSPECTS THAT THE PATIENT MAY HAVE A PLAVIX RESISTANCE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2 NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000636803

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| R THE PATIENT WAS ON PLAVIX PRIOR TO THE EVENT.| ASA POST PROCEDURE| THE PATIENT WAS PLACED ON PLAVIX AND